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临床试验/NCT01904617
NCT01904617已完成不适用

A Randomized Controlled Trial on the Effects of Rate and/or Presence of Dextrose on the Labor Course of Nulliparas

MemorialCare Health System1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2013年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
Length of labor

研究概览

简要总结

This randomized controlled trial aims to compare three groups of intravenous fluids and their impact on labor: 1) 125 mL/hr of 5% dextrose in normal saline 2) 250 mL/hr of normal saline 3) 250 mL/hr of 5% dextrose in normal saline

详细描述

Currently, patients who arrive to labor and delivery automatically receive IV fluid hydration as part of a standard order set. The current default IV fluid order is 125mL/hr of 5% dextrose, either in normal saline or lactated ringers.

Any patient delivering for the first time presenting to labor and delivery in active labor will be screened. If they meet inclusion requirements they will be offered enrollment.

Subjects will be blindly randomized to receive one of three different types of IV fluids:

  1. 5% dextrose Normal saline (Normal saline plus 5g/dl of glucose) at 125 mL/hr (the current LBMMC default inpatient IV order set)
  2. Normal saline (a solution containing sodium and chloride) at 250 mL/hr
  3. 2.5% dextrose Normal saline at 125 mL/hr
  • Management of labor will be at the discretion of the attending physician(s).
  • Maternal outcomes to be measured include: 1) total amount of IV fluids administered, 2) length of labor, 3) epidural use, 4) oxytocin use, 5) mode of delivery, 6) development of maternal infections or other morbidity such as postpartum hemorrhage.
  • Neonatal outcomes to be measured include: 1) birth weight, 2) Apgar scores, 3) hospital course (nursery placement and length of stay), 4) need for treatment of jaundice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •• Primiparous
  • •Singleton gestation
  • •Vertex presentation
  • •Spontaneous active labor with or without pitocin augmentation
  • •Gestational age > 36 weeks
  • •Cervical dilation 3 to 5 cm with or without ruptured membranes

排除标准

  • •• Multiparous
  • •Pregestational or gestational diabetes mellitus
  • •Preeclampsia at admission
  • •Previous cesarean section
  • •Non-vertex presentation
  • •Multiple gestation
  • •Chorioamnionitis at admission
  • •Intrauterine growth restriction (< 10th percentile)
  • •Patients admitted for induction
  • •BMI > 50

研究组 & 干预措施

D5NS at 125 mL/hr

Experimental

5% dextrose in normal saline at 125 mL/hr

干预措施: Dextrose (Other)

D2.5NS at 250mL/hr

Experimental

2.5% dextrose in normal saline at 250 mL/hr

干预措施: Dextrose (Other)

D5NS at 125 mL/hr

Experimental

5% dextrose in normal saline at 125 mL/hr

干预措施: Normal Saline (Other)

D2.5NS at 250mL/hr

Experimental

2.5% dextrose in normal saline at 250 mL/hr

干预措施: Normal Saline (Other)

NS at 250mL/hr

Experimental

Normal saline at 250mL/hr

干预措施: Normal Saline (Other)

结局指标

主要结局

Length of labor

时间窗: Time from fluid initiation to delivery

次要结局

  • Time of second stage of labor(Time from initiation of pushing to delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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